BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEGACY 1 IMPLANT

    MDR report key: 11937254 · Received June 4, 2021

    Report

    Report Number
    3001617766-2021-03363
    Event Type
    Malfunction
    Date Received
    June 4, 2021
    Date of Event
    April 20, 2021
    Report Date
    July 7, 2021
    Manufacturer
    IMPLANT DIRECT SYBRON MANUFACTURING LLC
    Product Code
    DZE
    UDI-DI
    10841307100850
    PMA / PMN Number
    K061319
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW-UP SUBMITTED TO REPORT DEVICE EVALUATION. UPDATED SECTION B4 FOR REPORT SUBMISSION DATE AND B6 TO REPORT DEVICE EVALUATION RESULTS. UPDATED D9 FOR DEVICE RETURN DATE, G1 FOR FOLLOW-UP REPORT SUBMITTER, G3 FOR AWARENESS DATE AND G6 FOR REPORT TYPE AND FOLLOW-UP NUMBER. UPDATED H2 FOR FOLLOW-UP TYPE, H3 FOR DEVICE EVALUATION STATUS AND H6 METHOD, RESULT AND CONCLUSION CODES.

    Additional Manufacturer Narrative · 1

    PATIENT'S WEIGHT WAS NOT PROVIDED. WHEN THE REQUESTED INFORMATION BECOMES AVAILABLE, A SUPPLEMENTARY REPORT WILL BE SUBMITTED. DEVICE EVALUATION RESULTS ARE NOT AVAILABLE. WHEN THE ANALYSIS IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, PRODUCT FRACTURE WAS OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    838049 LEGACY 1 IMPLANT DENTAL IMPLANT DZE IMPLANT DIRECT SYBRON MANUFACTURING LLC NA 72651 10841307100850

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR